FDA Updates Device Shortage Reporting Guide To Apply To Future PHEs

By Jessica Karins / November 20, 2023 at 12:09 PM
FDA has updated final guidance it put out during the COVID-19 pandemic that required device makers to share information about production interruptions or discontinuations to now also apply to future public health emergencies, while also urging companies to voluntarily share information about any device production challenges in the absence of a pandemic. The final guidance on notifications under Section 506J of the Food, Drug & Cosmetics Act, published Nov. 16, will apply to future public health emergencies (PHEs). The Coronavirus...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.